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Warning letter issued to S.R. Burzynski Manufacturing Facility, Texas on account of cGMP violations.

The U.S. Food and Drug Administration (FDA) inspected the clinical supply manufacturing facility, S.R. Burzynski Manufacturing Facility at 12707 Trinity St., Stafford, Texas and issued warning letter which summarizes significant violations of current good manufacturing practice (cGMP) for finished pharmaceuticals.

Some of the violations laid down in the warning letter are as detailed below:

• Firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes according to 21 CFR 211.113(b). Firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance according to 21 CFR 211.63. • Firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems for aseptic processing necessary to prevent contamination or mix ups according to 21 CFR 211.42(c)(10). • Firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination. 21 CFR 211.28(a). • Firm failed to subject each lot of a component with potential for microbiological contamination that is objectionable in view of its intended use to microbiological tests before use. 21 CFR 211.84(d)(6).

FDA has asked the firm to respond to the warning letter within 15 days of receiving it. Based on the nature of violations FDA has recommended the firm to hire a consultant qualified as set forth in 21 CFR 211.34 to assist in meeting cGMP requirements. However hiring a consultant does not remove the firm’s obligation of complying with cGMP in ensuring that the drugs manufactured have appropriate identity, strength, quality, and purity. FDA may withhold approval of any new applications or supplements listing of the firm as a drug product manufacturer until it corrects all the violations and compliance with cGMP is confirmed by FDA.



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