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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-80/
- Published: 2016-08-30T12:00:00.000Z
- Updated: 2026-09-14T21:27:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136658

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Amniotic Therapies, LLC** Farmers Branch, TX (8/17). Inspected 3/23-5/4\. CGMP deviations, adulterated: The amniotic-based products, which the firm describes as morselized, (purged) are also human cells, tissues, or cellular or tissue-based products, but they do not meet all of the criteria in 21 CFR 1271.10(a) and therefore do not qualify for regulation solely under Section 361 of the PHS Act \[42 USC 264\] and the regulations in 21 CFR Part 1271\. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect. The firm failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Environmental monitoring for the presence of microorganisms is not conducted during the manufacture of AlphaGEMS, AlphaGEMS Micro, and AlphaGEMS Nano, etc. (AlphaGEMS, AlphaGEMS Micro, and AlphaGEMS Nano products, non-penicillin drug products, etc.); 21 CFR 211.113(b), 211.100(a) & (b), 211.80(a), 211.160(b), 211.176  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517448.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517448.htm?ref=fdaweb.com)

**Brown’s Compounding Center, Inc.** Parker, CO (8/17). Inspected 7/28/14-8/11/14\. GMP deviations, adulterated, misbranded, unapproved drug products: None of the facility’s drug products included the following statements on the label: the statement, “This is a compounded drug”, and the date the drug was compounded. The facility also failed to submit a complete report to FDA upon initial registration as an outsourcing facility in 12/2014 identifying the drug products (sterile and non-sterile) that it compounded during the previous six-month period. It failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results to determine appropriate storage conditions and expiration dates, etc. (compounded drugs); FDCA 501(a)(2)(B), 502(f)(1), 503B(a)(10)(A), 503B(b)(2), 21 CFR 211.113(b), 211.166(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517278.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517278.htm?ref=fdaweb.com)

**Central Admixture Pharmacy Services** San Diego, CA (8/18). Inspected outsourcing facility in Allentown, PA 6/4-11/14 and 2/3-11/15\. Inspected San Diego outsourcing facility 8/4-8/14\. CGMP violations, adulterated, misbranded: At the Allentown facility, FDA investigators observed that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed. At the San Diego facility, FDA investigators observed that testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release, and procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed. Also, at both facilities, the firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed. The firm also fails to have any FDA-approved applications on file for its drug products, etc. (drug products); FDCA 502(f)(1), 505(a), 501(a)(2)(A)(B), 21 CFR 211.192, 211.113(b), 211.42(c)(10)(iv)(v)), 211.28(a), 211.166(a), 211.167(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518008.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518008.htm?ref=fdaweb.com)

**Simpro, LLC** Irving, TX (8/17). Inspected 6/17-7/7\. QSR deviations, adulterated: The firm failed to establish and maintain procedures for corrective and preventive action. It also failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to develop, maintain, and implement written Medical Device Reporting procedures, etc. (non-invasive blood pressure monitors, fingertip pulse oximeters, and portable fetal dopplers); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a), 803.17.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517345.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517345.htm?ref=fdaweb.com)

**Vitalife Inc. dba Tabak’s Health Products** Garden Grove, CA (6/20). Inspected 12/15, 16, 18/15\. Reviewed product labels and Web site at www.tabakshealthproducts.com in March. GMP deviations, adulterated, unapproved new drugs, misbranded: FDA reviewed the Web site and has determined that the firm takes orders there for the products Bendy, ExtraLuvli, and Graceful Look. The claims on the Web site establish that the products are drugs. For example, the site claims that Bendy “\[D\]ecreases joint pain” and Graceful Look “Helps to decrease UV-induced pigmentation.” Also, the firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing. The firm failed to periodically re-confirm the supplier’s certificate of analysis (COA) for applicable component specifications, etc. (Bendy, ExtraLuvli, Graceful Look, Arouser, Here-We-Grow); 21 CFR 111.103, 111.140(b)(1), 111.70(b)&(e), 111.75(a)(2)(ii)(D), 403(q)(1)(A), 403(q)(5)(F), 403(s)(2)(C)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517635.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517635.htm?ref=fdaweb.com)

**Xinxiang Tuoxin Biochemical Co., Ltd.** Xinxiang City, Henan, China (8/19). GMP deviations, adulterated: The firm failed to properly maintain equipment used in the manufacture of API and minimize the risk of contamination where open equipment is used. The FDA investigator observed non-dedicated drug manufacturing equipment in a state of disrepair. The FDA investigator observed chipped paint on the ceiling directly above open (purged), which could have fallen into open equipment and contaminated the API. In the firm’s response, it stated that it would repair parts of the facility and replace some of the equipment, but it did not provide details on the planned repairs and replacements, such as purchase orders and photographs of the renovations and replacements, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B).  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517942.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517942.htm?ref=fdaweb.com)