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# Latest Warning Letters
- URL: https://www.fdaweb.com/latest-warning-letters/
- Published: 2016-05-31T12:00:00.000Z
- Updated: 2026-09-14T21:06:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135791

**Bedford Pharmacy** Bedford, NH (5/18). Inspected 8/10-28/2015\. Serious deficiencies cited for firm’s practices for producing compounded sterile drug products. Investigators noted that firm’s aseptic processing occurs in an unclassified room and is turned off when not in use. The firm also failed to use a sporicidal agent and sterile wipes as part of its disinfection program for the aseptic processing area. Furthermore, it failed to demonstrate through appropriate studies that the aseptic processing area is able to provide adequate protection, etc. FDCA 501(a)(2)(A)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503430.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503430.htm?ref=fdaweb.com) **Complete Pharmacy and Medical Solutions** Miami Lakes, FL (3/10). Inspected 8/4-12/2014\. Investigators observed serious deficiencies in firm’s practices for producing compounded sterile drug products. Inspection noted that the firm did not use an effective sporicidal agent as part of the disinfection program for the clean room. In addition, it did not have adequate procedures to ensure glass vials and rubber stoppers were properly sterilized and depyrogenated. The firm also failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection for the ISO 5 area in which sterile products are being produced, etc. FDCA 503B, 502(f)(1).[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503555.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503555.htm?ref=fdaweb.com) **Corden Pharma Latina**Sermoneta, Italy (5/20). Inspected 5/21–29/2015\. GMP deviations for finished pharmaceuticals and active pharmaceutical ingredients (API). Inspectors found black grime and filth on floor tiles throughout the aseptic area. Firm’s cleaning procedure includes spraying water throughout the aseptic area, which allows stagnant water to collect underneath the aseptic filling machine. Inadequate sampling was cited because the firm does not take samples for analysis from the bulk solution during routine commercial production, etc. FDCA 501(a)(2)(B)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503559.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503559.htm?ref=fdaweb.com) **Megafine Pharma Limited**Mumbai India (5/19). Inspected 5/11-15/2015\. GMP deviations cited for for active pharmaceutical ingredients (API). Investigators noted the firm’s failure to ensure that, for each batch of intermediate and API, appropriate laboratory tests are conducted to determine conformance to specifications. Also cited its 501(a)(2)(B)[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503699.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503699.htm?ref=fdaweb.com)