Symbiotec Pharmalab Private Limited
Form 483 issued September 30, 2022 · Pithampur, India
- Inspection
- Sep 26 – Sep 30, 2022
- Investigators
- Rajiv R. Srivastava· Saleem A. Akhtar
- Observations
- 6
- Pages
- 8
- FEI number
- 3009298759
In short: On September 30, 2022, FDA issued a Form 483 with 6 observations to Symbiotec Pharmalab Private Limited in Pithampur, M.P (FEI 3009298759) after an inspection that ran Sep 26 – Sep 30, 2022. The investigators were Rajiv R. Srivastava and Saleem A. Akhtar. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control procedures are…
- 02
Your firm’s cleaning processes for non-dedicated equipment have not been…
- 03
Written procedures are not established to monitor the progress and control the performance of processing steps…
- 04
Incidents related to computerized systems that could potentially affect the quality of intermediates or APIs or…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symbiotec Pharmalab Private Limited?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Symbiotec Pharmalab Private Limited?
Rajiv R. Srivastava and Saleem A. Akhtar are named on this Form 483, for the inspection of Sep 26 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was Symbiotec Pharmalab Private Limited inspected by FDA?
The inspection ran Sep 26 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
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.