Latest FDA Warning Letters
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Conformis Inc. Billerica, MA (12/10): FDA inspected the company in November and cited quality system deficiencies with its Class 2 sterile orthopedic implants. For example, Conformis failed to establish and maintain procedures for implementing corrective and preventive actions. FDA also said it was concerned that the company continues to rely on a redacted process to assure sterility for product release instead of ensuring the process is operating under a validated state. To view the letter, click here.
Cross Brands Contract Filling Rockledge, FL (12/17): FDA inspected Cross Brands in June and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, Cross Brands lacked an adequate quality control unit with adequate facilities and procedures to ensure that drugs are manufactured in compliance with GMP regulations and meet established specifications for identity, strength, quality, and purity. To view the letter, click here.
Dercher Enterprises (doing business as Gordon Laboratories) Upper Darby, PA (9/13): FDA inspected the company in March and cited significant GMP for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to conduct, for each batch of drug product, appropriate laboratory testing to ensure that products do not contain objectionable microorganisms. To view the letter, click here.
GPT Pharmaceuticals Hyderabad, India (12/17): FDA inspected the company in June and cited significant GMP violations for finished pharmaceuticals. For example, GPT’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with FDA GMP requirements. Additionally, the company failed to clean, maintain, and sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of its drug products. To view the letter, click here.
Henan Kangdi Medical Devices Zhoukou Shi Henan Sheng, China (12/3): FDA inspected Henan Kangdi in March and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have an appropriate laboratory determination of satisfactory conformance to final specifications for its drug products, including the identity and strength of each active ingredient, prior to release. It also failed to conduct at least one test to verify the identity of each component in the drug products. And the company failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals. To view the letter, click here.
LNK International Hauppauge, NY (9/26): FDA inspected the company in February and cited significant GMP violations for finished pharmaceuticals. For example, LNK failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. To view the letter, click here.
Pharmalab Enterprises Hialeah, FL (12/10): FDA inspected the company in June and cited significant GMP violations for finished pharmaceuticals. For example, Pharmalab failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. Additionally, the company failed to perform adequate investigations concerning high microbial counts in its drug products. To view the letter, click here.
Unipharma Tamarac, FL (11/6): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, Unipharma failed to establish adequate written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport to possess. It also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. To view the letter, click here.
Wild Child WA Party Malaga WA (12/6): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, Wild Child failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for its drug products. It also failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport to possess. To view the letter, click here.