The reason for the above observation was;
The firm failed to ensure the equipment used in the manufacture of API is suitable for its intended use and is properly maintained.
For example:
• Rust-like residues were observed on product contact surfaces of the equipment labeled as clean, including xyz vessels and hoses.
• Tape was used on XYZ paddles to prevent black material from screws from contaminating the API.
• A XYZ was used to attach an XYZ to a piece of equipment.
• Several holes were observed in an XYZ.
The firm lacked a procedure to qualify the manufacturing and quality control laboratory equipment.
Firm manufacture and tests XYZ API in unqualified equipment.
In the firm's response, the firm indicated that the rust-like residue cannot be rust.
USFDA stated the shared response was inadequate.
As firm failed to identify the source of the brownish residue on the XYZ vessels and hoses.
The firm's response does not adequately address the poor condition and state of disrepair of the equipment which increases the risk of foreign material contaminating the API. Notably, API is intended for the production of a sterile injectable drug product.
Whenever you will take objection to the rust in the plant, you will get the reply as it is common due to fumes, acids, and reactions and........ and ........ and......
SOPs are designed as per the guidelines, and procedures shall be prepared and will be in place to solve this problem.
But still, you will be able to find such observations in Warning letters.
Why?
I think lack of implementation.
Lack of compliance with the SOPs and procedures.
As a result, the company got a warning letter with the above observation.
Go take a round of your facility and take action to fill the gaps if you find them.