FDA 483 - Millers of Wyckoff, Inc. - July 16, 2015

An FDA Form 483 was issued following an inspection on June 29-30, 2015, detailing multiple deficiencies in the facility's sterile drug product manufacturing.

**Key Violations and Observations:**

* **Aseptic Technique Deficiencies:** Procedures to prevent microbiological contamination were not followed. Observations included: * Materials (syringes, gloves, vials) not wiped with sterile disinfectant before entering the aseptic area. * Incomplete sanitization of vial stoppers. * Processing performed on sterile glove wrappers instead of the work surface. * Gloves not changed or sanitized between different products/lots. * Disposable lab coats reused after falling on the floor. * **Lack of Stability Data and Expiration Dates:** Drug products lacked expiration dates supported by stability data, leading to unvalidated beyond-use dates (up to 3 months) for preserved and non-preserved sterile preparations. Container closure integrity was not established. Examples included Bupivacaine, Procaine, Magnesium Sulfate, Methylcobalamin, Cyclopentolate Ophthalmic, and Methylprednisolone eye drops. Sterility assurance for redacted sterilized products was also lacking. * **Inadequate Sterility and Endotoxin Testing:** * No documented sterility test methods for most products, except Trimix. * Executed sterility testing was not confirmed to be compendial or validated