这封483是由Teresa I. Navas和Justin A. Boyd两位检查员在2024年7月29日到8月2日在检查Global Calcium公司位于泰米尔纳德邦（Tamil Nadu）的工厂后发出的。这两位检查员都不简单，根据识林483和检查员数据库，Teresa I. Navas最近常和Justin A. Boyd搭档检查印度知名企业（Cipla和Sun），还曾经检查过天宇和华海。
而Justin A. Boyd更是FDA杀手级检查员，在识林483和检查员数据库有超过50条记录，显示他从2019年开始的过去5年，集中精力在印度检查。不知是幸运还是不幸，这位检查结果超过1/3都是OAI（官方行动指示，即检查不通过）的检查员，因为疫情和非疫情的原因，顶住了美国国会施加给FDA一轮又一轮严查的压力，最近没来中国检查。
Production records do not contain complete information relating to the production and control of each batch.
生产记录未包含与每批次生产和控制相关的完整信息。
The Production Head stated that he directed employees to create batch records and supporting records including cleaning records and equipment use logs for activities that did not actually occur in Plant. Plant is intended to be used for the manufacturing of the US market product (b)(4) Injection Grade API
The Plant (b)(4) Manager stated he used Microsoft Excel to generate plans with dates, production start and stop times, sampling dates, and product weights to instruct employees how to create these records for activities that did not occur. Production employees present (b)(4) of Plant (b)(4) participated in the creation of these batch records, cleaning records, and equipment logs for activities that did not occur. Duplicate sets of cleaning records and equipment logs were created for the same time period and document different batches being manufactured on the same equipment, at the same time
On July 29, 2024, examples of the plans, which were identified by the manager of Plant (b)(4) as being used in the fabrication of batch records for activities that did not occur, were observed in the Plant (b)(4) production office attached to blank batch records. This included plans associated with (b)(4) batches),(b)(4) Powder (b)(4) Batches),(b)(4) Liquid (b)(4) batches), and (b)(4) batch).
All Microsoft Excel files present on the Plant (b)(4) Manager's computer, where the plans for fabricating batch records were created, were deleted by the Production Head on the evening of July 29, 2024, preventing additional plans that may have been present on the computer from being reviewed during the inspection.
Review of batch records, cleaning records, and equipment use logs for (b)(4) Injection API released for the US market identified the following conflicts that demonstrate the records are not accurate, since at least January of 2023:
