483
Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty PharmacyVitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy – FDA 483, Aug 2, 2019
Record Details
Vitalab Pharmacy, Inc., DBA Vasco Rx Specialty Pharmacy, a producer of sterile and non-sterile drugs in Phoenix, AZ, was cited for using non-pharmaceutical grade components in drug product formulations. Specifically, the firm failed to assess microbial or other properties of a component used in numerous non-sterile oral solutions and suspensions, indicating a significant quality control deficiency.
- Inspection date
- August 2, 2019
- Product type
- drugs
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ID · ac532169-eb14-4eb4-a84c-4ca7000a07aa
Violation Codes3
21 CFR 331(c)FD&C Act 905(j)21 U.S.C. 324(a)(4)
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