FDA Inspection
Kramer DetergentsKramer Detergents – FDA Inspection, Jun 16, 2009
Record Details
This FDA Inspection record concerns Kramer Detergents, with an inspection on June 16, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kramer Detergents
- Inspection Date
- June 16, 2009
- Product Type
- Drugs
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ID · 61c00868-f031-4768-b08c-424aa9334675
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589577
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.22(a)Lack of quality control unit
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