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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-70/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135938

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

**Austin Biotechnology Inc.** Taipei, Taiwan (6/2). Inspected 5/28-29/15\. GMP deviations, adulterated: The firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. It failed to ensure that its drug products bore an expiration date that was supported by appropriate stability testing. Also, the firm failed to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit, etc. (drug products); FDCA 501(a)(2)(B), 21 CFR 211.22(a), 211.100(a), 211.137(a), 211.166(a), 211.84(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505558.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505558.htm?ref=fdaweb.com)

**The Compounding Pharmacy of America, Inc.** (6/9). Inspected 5/12-15 and 21/15\. CGMP violations, adulterated, misbranded: Investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. For example, during aseptic processing, investigators observed technicians preparing sterile drugs in street clothes, without doning proper gowning. Also, this process took place in an unclassified room with no HEPA filtration and the firm did not use a sporicidal agent as part of the disinfection program for the aseptic processing areas, etc. (Fentanyl 7,000 mcg and Bupivacaine 40 mg); FDCA 502(f)(1), 505(a), 501(a)(2)(A)&(B), 21 CFR 211.113(b), 211.42(c)(10)(ii)(iii)&(iv)&(v), 211.28(a), 211.166(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506080.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506080.htm?ref=fdaweb.com)

**Focus Laboratories, Inc.** North Little Rock, AR (6/3). Reviewed Web sites at www.focuslaboratories.com and www.mytozal.com. Unapproved new drug, misbranded: The labeling claims on these Web sites represent this product as a medical food for age-related macular degeneration. FDA says the labeling is false and misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food. FDA is not aware of any distinctive nutritional requirements or unique nutrient needs for individuals with age related macular degeneration, and therefore Tozal does not meet the regulatory criterion for medical foods set forth in 21 CFR 101.9(j)(8)(ii), etc. (Tozal, FreshKote); FDCA 502(f)(1), 505(a), 403(a)(1)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505550.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505550.htm?ref=fdaweb.com)

**PCP LV, LLC dba Pinnacle Compounding Pharmacy** (5/23). Violations, adulterated: FDA investigators noted that production occurred in the cleanroom while the positive pressure differential to the anteroom was below the firm’s specification. Also, the environmental monitoring samples were incubated in a hallway at uncontrolled room temperature, which could potentially bias the results. The firm used an expired disinfectant and did not follow the manufacturer’s instructions to ensure an adequate contact time for the sporicidal agent, etc. (compounded drugs); FDCA 501(a)(2)(A)(B), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)(iii)&(iv)&(v), 211.28(a), 211.167(a), 211.137(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505566.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505566.htm?ref=fdaweb.com)

**People’s Custom Rx and Clinical Care, LLC** Memphis, TN (6/6). Inspected 7/20-24 and 27-29/15\. Unapproved new drugs, adulterated, misbranded: FDA investigators observed that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. The investigators also observed unsanitary conditions such as failure to use a sporicidal agent and the use of non-sterile disinfectants for daily cleaning of the ISO 5 hoods and clean room. Personnel did not sanitize the components used during aseptic production (e.g., sterile syringes, sterile needles, compounding solution) prior to placing them inside the aseptic areas (ISO 5 and cleanroom), etc. (drug products); FDCA 501(a)(2)(A)(B), 502(f)(1)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506145.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506145.htm?ref=fdaweb.com)

**Thomas Veterinary Services, PLC** Smiths Grove, KY (6/2). Inspected 9/28 and 10/8/15\. The veterinary practice caused the new animal drug Nuflor Injectable Solution (florfenicol, NADA #141-063), to be unsafe. The practice failed to maintain complete records for the extralabel use of the new animal drug Nuflor it prescribed to treat a dairy cow identified with (purged) for bovine respiratory disease. When prescribing Nuflor in an extralabel manner to treat a dairy cow the practice failed to take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment, etc. (Nuflor injectable solution): FDCA 501(a)(5), 21 CFR 530.5, 530.20(a)(2)(ii), 530.20(a)(2)(iv)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm504932.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm504932.htm?ref=fdaweb.com)