FDA Inspection
Scarguard Labs, LLCScarguard Labs, LLC – FDA Inspection, Apr 6, 2011
Record Details
This FDA Inspection record concerns Scarguard Labs, LLC, with an inspection on April 6, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Scarguard Labs, LLC
- Inspection Date
- April 6, 2011
- Product Type
- Drugs
View Company Profile
ID · 2ea8dabb-1089-422f-802c-d286130d6b2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718434
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.186(b)(4)Variation in the Amount of Components Used
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.180(e)(1)Review of representative number of batches
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