Jamol Laboratories, Inc.

Warning LetterOpen

Mr. Emil Scott Lucia Co-Owner/President Jamol Laboratories, Inc. 13 Ackerman Avenue Emerson , NJ 07630 United States (b)(6), (b)(7)(C)FEI 2211383Issued Jul 13, 2023Division of Pharmaceutical Quality Operations I

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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 2211383.

Violations3

Issue DateJul 13, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Jamol Laboratories, Inc.
Location: Mr. Emil Scott Lucia Co-Owner/President Jamol Laboratories, Inc. 13 Ackerman Avenue Emerson , NJ 07630 United States (b)(6), (b)(7)(C)
FEI Number: 2211383
Country: United States
Issue Date: July 13, 2023
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Jamol Laboratories, Inc. was cited for manufacturing adulterated over-the-counter Ponaris Nasal Emollient drug products under insanitary conditions and in violation of Current Good Manufacturing Practice (CGMP) regulations. During a December 2022 to January 2023 inspection of their Emerson, New Jersey facility, FDA investigators found the multipurpose manufacturing space in a state of disrepair with poor cleaning and maintenance, including a dead insect, exposed ceiling, inadequate ventilation, and debris-covered equipment positioned in a corridor. The firm lacked adequate controls to maintain a clean production environment and prevent product contamination, resulting in violations of 21 CFR parts 210 and 211 governing finished pharmaceutical manufacturing.

Jamol Laboratories, Inc. FDA Warning Letter, July 13, 2023