Smit Patel Managing
Director and Marketing Head
Orchid Lifesciences
68-72 Tribhuvan Industrial Estate
Nr. Road No. 11, Kathwada
Ahmedabad, Kathwada 382430
India
smit@orchidlifesciences.comFEI 3015154915Issued Aug 3, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015154915.
Violations3
Issue DateAug 3, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Orchid Lifesciences
Location
Smit Patel Managing
Director and Marketing Head
Orchid Lifesciences
68-72 Tribhuvan Industrial Estate
Nr. Road No. 11, Kathwada
Ahmedabad, Kathwada 382430
India
smit@orchidlifesciences.com
FEI Number
3015154915
Country
India
Issue Date
August 03, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Orchid Lifesciences, an OTC drug manufacturer in India, failed to meet Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products including toothpaste and topical analgesics. The company did not conduct required identity testing on incoming components at high risk of contamination, specifically failing to adequately test glycerin, propylene glycol, and sorbitol solution for diethylene glycol (DEG) or ethylene glycol (EG) contamination in violation of 21 CFR 211.84(d)(1). This warning followed an FDA inspection and the company's response to a January 25, 2023 records request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.
Orchid Lifesciences FDA Warning Letter, August 3, 2023
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