FDA Inspection
BOSTON NUTRACEUTICAL PRODUCTION SL.BOSTON NUTRACEUTICAL PRODUCTION SL. – FDA Inspection, Jun 14, 2024
Record Details
This FDA Inspection record concerns BOSTON NUTRACEUTICAL PRODUCTION SL., with an inspection on June 14, 2024, covering drugs.
- Inspection Date
- June 14, 2024
- Product Type
- Drugs
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ID · 77f9c47f-b3ca-4d4f-ac43-2c2a974f6600
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237754
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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