FDA Inspection
Corporativo Serysi, S. De R.L. De C.V.Corporativo Serysi, S. De R.L. De C.V. – FDA Inspection, Aug 16, 2019
Record Details
This FDA Inspection record concerns Corporativo Serysi, S. De R.L. De C.V., with an inspection on August 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Joan M. Cantellops Figueroa (Issuing Officer)
- Vilmary Negron Rodriguez (Issuing Officer)
View Company Profile
ID · 8b5e3387-acf6-491d-8252-4adb3d247287
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099721
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(e)Test methods
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