Symbiotec Pharmalab Private Limited
Form 483 issued July 5, 2019 · Pithampur, India
- Inspection
- Jul 1 – Jul 5, 2019
- Investigators
- Christopher Keating· Ralph H. Vocque
- Observations
- 4
- Pages
- 3
- FEI number
- 3009298759
In short: On July 5, 2019, FDA issued a Form 483 with 4 observations to Symbiotec Pharmalab Private Limited in Pithampur, M.P (FEI 3009298759) after an inspection that ran Jul 1 – Jul 5, 2019. The investigators were Christopher Keating and Ralph H. Vocque. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory investigations for out-of-specification results and systems suitability failures in the and joa QC…
- 02
Critical process parameters identified in the manufacture of APIs and API intermediates are…
- 03
Cleaning validation master plans are not of suitable design to effectively demonstrate the robustness of the…
- 04
Qualifications and validations of equipment and production processes…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSymbiotec Pharmalab Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symbiotec Pharmalab Private Limited?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Symbiotec Pharmalab Private Limited?
Christopher Keating and Ralph H. Vocque are named on this Form 483, for the inspection of Jul 1 – Jul 5, 2019. Each investigator has a profile showing what they cite most.
When was Symbiotec Pharmalab Private Limited inspected by FDA?
The inspection ran Jul 1 – Jul 5, 2019, and the Form 483 is dated July 5, 2019.
How do I get the full Form 483 for Symbiotec Pharmalab Private Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.